Global Atrophie Biomarker Evaluation Study (GABiE)

Boehringer Ingelheim

Status: Terminated

Conditions: Age-related Macular Degeneration

Treatments: Diagnostic Test: Diagnostics

Study type: Observational

Funder types: Industry

Identifiers

NCT03935126

0352-2110

Details and patient eligibility

About

To investigate the use of microperimetry and SS-OCT in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.

Enrollment: 3 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study

• Age >=60 years

• Ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye

• GA lesion in the study eye must reside completely within the FAF imaging field (Field 2- 30 degree image centered on the fovea)

• BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye

• Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye

  • The total GA lesion size >=1.2 mm^2 (approximately >=0.5 disc area [DA]) and <=17.78 mm^2 (approximately <=7 DA) and must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
  • If GA is multifocal, at least 1 focal lesion must be >=1.2 mm^2 (approximately >=0.5 DA)

• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye

Exclusion criteria

• GA in either eye due to causes other than AMD (for example, monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
• Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye
• Mean sensitivity difference > 3 dB between the two microperimetry examinations in the screening visit.
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
• Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
• Prior treatment with Visudyne ®, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
• History of prophylactic subthreshold laser treatment for AMD in the study eye
• Further criteria apply.

Trial design

3 participants in 1 patient group

All patients

Treatment:

Diagnostic Test: Diagnostics